by Matthew Perrone
WASHINGTON (AP) – President Joe Biden is betting millions more on rapid, at-home tests to help curb the latest deadly wave of the COVID-19 pandemic, which is overloading hospitals and closing classes across the country. threatening to shut down.
But the test has already disappeared from pharmacy shelves in many parts of the US, and manufacturers have warned they will take weeks to ramp up production after scaling it back amid a slump in demand in the summer.
The latest shortfall is another painful reminder that the US has yet to successfully manage its COVID-19 testing arsenal, let alone deploy it in the systematic manner needed to quickly crush the outbreak in schools, workplaces and communities.
Experts say encouraging signs last spring led to false belief about the shrinking role for tests: falling case numbers, rising vaccination rates and guidance from health officials that vaccinated people could skip mass testing. Huh. Officials recently reversed that advice as there was a renewed rise in cases and deaths driven by the Delta version.
“For all of us, the June deadline was a combination of optimism and pride that made us believe it was over,” said Mara Espinol, a health industry researcher at Arizona State University who is a researcher on COVID-19 testing. has become the leading authority. supply.
Colorado’s Mesa County is among local governments that have stopped offering rapid testing to the general public as part of their free testing programs.
“We were seeing a decrease in tests throughout the county, so we’re really prioritizing supplies for our school districts for testing, to help them when they need it,” County spokeswoman Stephanie Bush said. She notes that tests that are processed in laboratories — which take longer to produce results — remain plentiful.
In fact, parts of the US testing system are performing better than during the earlier boom. The large commercial laboratories that process most of the tests performed at hospitals and testing sites still report much higher capacity. LabCorp, one of the largest lab chains, said last week it was delivering the results of 150,000 tests daily, with the capacity to double that number.
Still, rapid tests have a clear advantage that they can be done anywhere and have a turnaround time of 20 minutes, but most school testing programs still rely on tests processed in laboratories, which take a day or two. return results.
In general, the US has been far more cautious about adopting rapid, home testing technology than countries such as the UK, which have rolled it out widely. The Food and Drug Administration has authorized only half a dozen such tests, compared to more than 400 laboratory tests. Many experts, including FDA regulators, still consider the laboratory technology the “gold standard” for accuracy because it can detect even minute levels of virus in the nose.
But in his speech this month announcing the new vaccine mandate, Biden highlighted the rapid tests, saying the government would buy 280 million of them, as he also called for all schools to establish regular testing programs. Biden said the federal government would use the Defense Production Act to make sure manufacturers have the raw materials they need to test.
If those plans sound familiar, that’s because they were part of Biden’s original strategy for dealing with COVID-19, released in January.
A spokeswoman for the Department of Health and Human Services said the latest actions “build on earlier initiatives” as the demand for Delta variant-powered surge testing increases.
HHS has announced some details of a $2 billion plan to buy rapid tests. For now, retail chains like CVS and Walgreens have put limits on how many home tests customers can buy.
Abbott Laboratories – the country’s largest rapid test maker – said it is currently producing “tens of millions” of its Binex Now tests per month and is working to increase capacity in the coming weeks.
The New York Times recently reported that in the summer Abbott closed one of its factories, laid off employees and destroyed some test components.
Abbott said those decisions came after vaccinations climbed and testing demand declined. According to Abbott, the destroyed supplies had a limited shelf life and were not viable for sale in the US or for donation overseas.
“It is now very clear that testing is an essential companion to vaccines and Abbott is moving again,” a company spokesperson said.
The Biden administration’s buying plans should help stabilize supplies. But testing experts said the government could have stepped in months earlier.
“We can’t let the market determine our test supply, which is what happened here,” said Scott Baker of the Association of Public Health Laboratories. “These tests are necessary for public health purposes, so we have to have supplies at all times.”
Baker’s group and others have seen a surge in demand for the test for weeks. And while labs are still operating well below levels seen last winter, there are unknowns in which Biden’s push for increased testing at schools and workplaces will affect them.
Testing policies vary widely by schools and states. Some districts routinely screen all students — including Los Angeles, Baltimore, and San Antonio. But many other districts do not do testing at all.
A recent survey of 100 large districts found that less than 15% of students required any testing. That’s despite $10 billion in federal funding made available last spring to set up testing programs.
Several districts said the benefits of repeated testing outweigh the logistical headache of setting up programs and dropping students. Some states also attempted to return testing funding to the federal government.
The Biden plan has no penalties for schools that don’t test, a factor that could limit going forward.
To make rapid tests more affordable, large retailers such as Wal-Mart and Kroger have agreed to sell them at a 35% discount for the next three months. But the cheapest test — Abbott’s Binex Now — will still sell for around $15 for a two-pack, out of reach for some families who want to test themselves frequently.
Other tests will cost $35 or more, even after the discount.
This is very different from countries such as the UK and Germany that distribute rapid tests either for free or for prices in the low single digits.
But with the federal government investing billions in rapid tests, testing advocates are hopeful that more options — and cheaper ones — may eventually hit the market.
“When you’re not winning a war you need to change your strategy, and I think it’s a great first step to do that,” Aspinall said.
This story has been updated to correct the name of Baker’s group at the Association of Public Health Laboratories.
Follow Matthew Perrone on Twitter: @AP_FDAwriter
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